90%Confidence
0Views
FDASource
2026-04-17Date
Summary
Appco Pharma's third nitrosamine impurity finding for Prazosin 5mg capsules confirms systemic manufacturing problems affecting their entire Prazosin product line. This recurring issue may trigger FDA enforcement actions and damage Biocon Pharma's brand reputation.
Actionable: Develop contingency plans for Prazosin supply chain disruptions and consider regulatory actions against Appco Pharma.
AI Confidence: 90%
Data Points
firmAppco Pharma LLC
classificationClass II
statusOngoing
distributionU.S.A. Nationwide
productPrazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma
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